The present invention is directed to medical and laboratory fluid specimen collecting and testing apparatus, and more specifically to an apparatus for detecting the presence of specific antigens in a biological fluid such as urine and collecting urinary sediments from the urine.
Under normal conditions, urine contains a small number of cells and other particulate matter shed from the entire length of the urinary tract. These materials are usually known as urinary sediments. Typical urinary sediments consist of red blood cells, white blood cells, epithelial cells, casts, mucus and crystals. In addition, sporatic urinary sediment such as bacteria, yeast, parasites and spermatozoa occur in patients suffering from various types of disorders or engaging in particular activities. Examination of urinary sedimentation is a routine procedure in urinanalysis. With disease, these cells as well as other formed elements are often increased and may help to localize the site and type of injury. For example, excessive numbers of red blood cells may indicate tumor, stones or imflammation. Excessive number of leukocytes may indicate infection or other inflammatory disease. In contrast to the hypocellular nature of normal urine, neoplastic cells (e.g., transitional, squamous and columnar cells) are shed more frequently in malignant conditions of the bladder epithelium.
Immunoassay works upon the simple principle that is the specific recognition of an antigen by an antibody. Thus specific antigen detection and quantification requires an antibody which recognizes the uniqueness of an antigen. The antigen binding site of antibodies recognizes about six amino acids or their equivalent in mass. One unique binding site serves as an identifying marker for that protein.
When a definitive antibody for a given antigen is available it is used to identify the antigen in the sample mixture. Once the antibody combines with the antigen a means is needed to recognize the resulting complex. There presently exists a need to concentrate antigens from volumes of fluid when the antigen is not present in measurable quantities in specific fluid volumes.
It is generally necessary in diagnosing and testing for many diseases to collect biological fluids from a patient. Although blood, urine and cerebrospinal fluids are the most common specimens received for diagnosis, other fluids such as seminal, synovial, pleural, pericardial, peritoneal, amniotic and sweat fluids are associated with specific conditions and diseases. It is important during the collection handling of biological fluid specimens that the potential of specimen deterioration, contamination and the spread of any infection from the specimen be minimized. While urine is commonly collected in 100 ml containers, the actual urine testing is commonly conducted with relatively small amounts of sample around 0.2-0.5 ml in volume. Thus because of the small test quantity, cancer producing antigen can only be ascertained after the cancer is in an advanced or late tumor stage. The rest of the urine sample is used for further testing, frozen or is thrown away. Additional problems occur in shipment when dealing with urine because of the relatively large volume of fluid involved in the collection specimen samples. There is also the risk of sample deterioration because of the relatively short sample shelf life of urine unless kept in specific temperature conditions. In addition there is also the potential for specimen damage or spillage during the collection and/or shipment process as well as the potential for destruction of certain molecular components of the specimen such as antigens contained therein as well as cellular materials such as urinary sediments, because the packaging does not protect the urine or causes chemical changes in the different components which will negate the test results or result in false data being obtained when the specimen is tested.
There currently exists a need to concentrate molecular components of urine and separately concentrate the urinary sediments for diagnosing the presence of cancer at an early stage in the development of the cancer
A typical specimen collecting apparatus is shown by U.S. Pat. No. 4,741,346. This apparatus includes a base stand which supports the specimen vial in an upright position. A funnel is inserted in the open end of the specimen vial and surrounds and encloses the upper portion of the vial. The base stand has an upwardly extending tubular wall which at least partially surrounds the vial in connection with the cap and allows the user to remove the vial without touching the surface or coming in contact with the specimen. Examples of various types of liquid containers for collecting and transporting urine are shown by U.S. Pat. Nos. 3,777,739; 3,881,465; 4,042,337; 4,084,937; 4,244,920; 4,492,258 and 4,700,714.
Another specimen collection device shown by U.S. Pat. No. 4,040,791 discloses a collection receptacle having a nipple upon which is mounted a specimen container which receives a predetermined amount of the specimen in a sealed condition. The specimen container is provided with an integally formed cap which is placed over the opening in which the collector nipple is inserted U.S. Pat. No. 4,557,274 discloses a midstream urine collector having a funnel which transmits urine into a cup member which is covered by a membrane cover.
A combined strip testing device and collection apparatus is shown by U.S. Pat. No. 4,473,530 and is directed to an apparatus which integrates testing and collection by having chemical reagent test strips present within the tube together with specific gravity reading means allowing immediate testing of the urine. U.S. Pat. No. 4,573,983 is directed towards a liquid collection system having an antiseptic member on the discharge section which uses a filter of air and bacteria impervious material to filter the urine.
It is therefore desirable to provide an easy to handle disposable apparatus and method which transports a fluid sample such as urine through a specific immobilized antibody bead bed to capture a concentrated amount of antigen and urinary sediments from the urine allowing more sensitive cancer detection from the sample while also providing that the test specimen can be compactly stored for a period of time in concentrated form allowing cancer testing to be performed quickly and accurately by distal testing facilities.